AnesthesiaNCT03319303
What Effect Does Intubation Have on Regional Lung Ventilation?
An observational study of Anesthesia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
During any general anaesthetic which involves muscle relaxation artificial breathing is required. This is most commonly provided by pushing air under pressure (positive pressure ventilation) into the lungs via a tube in the airway (the tracheal tube). Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Anesthesia
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients attending for a surgical procedure are eligible and will be approached.
Who may be able to join
- Willing and able to consent
- undergoing a surgical procedure for which the anaesthetic technique includes muscle relaxation, intubation and ventilation for clinical care.
Who cannot join
- Unwilling or unable to consent
- co-existant respiratory disease associated with known abnormalities of ventilation/perfusion matching. This includes chronic obstructive pulmonary disease, asthma, or abnormalities of the chest wall or abdomen affecting ventilation e.g. morbid obesity
- Requirement for double-lumen tracheal tube for clinical care
- increased risk of regurgitation/aspiration e.g. pregnancy, symptomatic acid reflux, structural abnormalities of the gastro-intestinal tract (e.g. hiatus hernia)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
Official title: Observational Study of the Effect of Tracheal Intubation and Tracheal Tube Position on Regional Lung Ventilation During General Anaesthesia
During any general anaesthetic which involves muscle relaxation artificial breathing is required. This is most commonly provided by pushing air under pressure (positive pressure ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been observed for many years that with this form of breathing the distribution of gas within the lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper parts of the lung than lower parts. This change in how the gas is distributed can lead to problems with how well oxygen is taken up by blood and carbon dioxide removed from the body. Previous work using mathematical modelling has found that the position of the tracheal tube might affect air distribution, but this has previously been difficult to study in 'real life', requiring the use of radioactive dyes and computerised tomography (CT). However a bedside test is now available which allows us to study these changes rapidly and non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor of lung ventilation.
This study aims to investigate the effect of tracheal intubation on regional ventilation of the lungs by comparing measurements before and after the patient is anaesthetised and intubated. The investgiators aim to show whether altered patterns of ventilation are caused by patients simply being asleep and ventilated, or whether these changes are due to the use of a tracheal tube itself. The exact effect of tube position will also be studied by measuring ventilation as the tube is deliberately advanced until it enters one of the lungs. This will give us information about the ideal position for a tube within the trachea to promote optimal ventilation patterns within the lungs
- Conditions
- Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Manipulation of the tracheal tube and deliberate insertion into a right or left main bronchus
General anaesthesia will then be induced, and when the participant is asleep a further set of measurements will be taken using the Electrical impedance tomography (EIT) belt whilst ventilation is maintained using the normal bag-mask ventilation technique used by anaesthetists in the first few minutes of the anaesthetic. Following this, the trachea will be intubated by the anaesthetist clinically responsible for the patient, and a further set of EIT measurements taken.
Measured: 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start20 Oct 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319303
- Sponsor's protocol ID
- AN17/97842
- Status last verified
- Jun 2018
- First submitted
- 19 Oct 2017
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Effect of Tracheal Intubation and Tracheal Tube Position on Regional Lung Ventilation During General Anaesthesia
- ClinicalTrials.gov ID
- NCT03319303
- Acronym / sponsor ID
- AN17/97842
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During any general anaesthetic which involves muscle relaxation artificial breathing is required. This is most commonly provided by pushing air under pressure (positive pressure ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been observed for many years that with this form of breathing the distribution of gas within the lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper parts of the lung than lower parts. This change in how the gas is distributed can lead to problems with how well oxygen is taken up by blood and carbon dioxide removed from the body. Previous work using mathematical modelling has found that the position of the tracheal tube might affect air distribution, but this has previously been difficult to study in 'real life', requiring the use of radioactive dyes and computerised tomography (CT). However a bedside test is now available which allows us to study these changes rapidly and non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor of lung ventilation.
This study aims to investigate the effect of tracheal intubation on regional ventilation of the lungs by comparing measurements before and after the patient is anaesthetised and intubated. The investgiators aim to show whether altered patterns of ventilation are caused by patients simply being asleep and ventilated, or whether these changes are due to the use of a tracheal tube itself. The exact effect of tube position will also be studied by measuring ventilation as the tube is deliberately advanced until it enters one of the lungs. This will give us information about the ideal position for a tube within the trachea to promote optimal ventilation patterns within the lungs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attending for a surgical procedure are eligible and will be approached.
Key inclusion criteria (2 listed)
- Willing and able to consent
- undergoing a surgical procedure for which the anaesthetic technique includes muscle relaxation, intubation and ventilation for clinical care.
Key exclusion criteria (4 listed)
- Unwilling or unable to consent
- co-existant respiratory disease associated with known abnormalities of ventilation/perfusion matching. This includes chronic obstructive pulmonary disease, asthma, or abnormalities of the chest wall or abdomen affecting ventilation e.g. morbid obesity
- Requirement for double-lumen tracheal tube for clinical care
- increased risk of regurgitation/aspiration e.g. pregnancy, symptomatic acid reflux, structural abnormalities of the gastro-intestinal tract (e.g. hiatus hernia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Manipulation of the tracheal tube and deliberate insertion into a right or left main bronchus
Time frame: 20 mins
General anaesthesia will then be induced, and when the participant is asleep a further set of measurements will be taken using the Electrical impedance tomography (EIT) belt whilst ventilation is maintained using the normal bag-mask ventilation technique used by anaesthetists in the first few minutes of the anaesthetic. Following this, the trachea will be intubated by the anaesthetist clinically responsible for the patient, and a further set of EIT measurements taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manipulation of the tracheal tube and deliberate insertion into a right or left main bronchus (time frame: 20 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.